Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-05 @ 8:18 PM
Study NCT ID:
NCT06593795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001946', 'term': 'Breech Presentation'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate ECV success rate.', 'timeFrame': 'during the procedure', 'description': 'to evaluate clinical and ultrasound parameters possibly predictive of the success of ECV. This will allow the creation of a predictive model for adequate counseling for the women undergoing the procedure for the cephalic version of fetuses in breech presentation at term of pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breech', 'external cephalic version', 'ultrasound', 'c-section'], 'conditions': ['Breech Fetal Presentation', 'Breech Presentation of Fetus with Successful Version', 'Vaginal Delivery', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate possible predictors for the successful od external cephalic version (ECV), a procedure that is indicated in your case due to breech presentation of your baby and your desire to avoid cesarean section. Before the procedure, a detailed ultrasound scan will be performed to measure several parameters. After the procedure we will collect data about the duration, outcome and eventual complications of ECV.', 'detailedDescription': 'Pregnant women with a diagnosis of fetal breech presentation, desirous of an attempt of ECV after counseling and written consent and hospitalized for the procedure will be consecutively enrolled. The following anonymous data will be recorded:\n\n* Demographic and anthropometric data (i.e., age (y), ethnicity, height (m), weight (kg), BMI);\n* Parity\n* Gestational Age (weeks + days)\n\nBefore ECV attempt, the following evaluations will be performed:\n\n* Vaginal examination to evaluate the cervical dilatation and the level of presenting part (floating or not floating)\n* Fetal transvaginal ultrasound reporting:\n\n * biometry (BPD, HC, AC, FL, EFW);\n * Occiput position (right, left);\n * Back position (anterior, posterior, right, left);\n * Breech variant (footling, frank, complete);\n * Fetal leg posture (extended, flexed)\n * Placental localization;\n * Amniotic Fluid Index (AFI);\n * Fore-bag of amniotic fluid;\n * Eventual presence of nuchal cords;\n * Fetal head ballottement (yes, no);\n * Occiput-spine angle (see Figure 1)\n\nThen, all the participants will undergo a transabdominal ultrasound-guided ECV in a semi-sitting position by the same expert operator (B.C.). After the procedure, the following data will be collected:\n\n* Success (yes, no)\n* Duration of the procedure (min);\n* Direction of fetal flip in case of success (frontside flip, backside flip)\n* Pain perception in Numerical Rating Scale (NRS) (1-10);\n* Reason for terminating the procedure (success, failure, pain, uterine contractions, non-reassuring fetal conditions)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We will consecutively enroll all pregnant women at the term of gestation with a fetal breech presentation undergoing ECV attempt after counseling at Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome, satisfying the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 y.o.;\n* Pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ECV;\n* Singleton;\n* At term (≥ 37 weeks);\n* Breech presentation;\n* No previous uterine scars or other indications for elective C-section;\n* Signed written informed consent to study participation.\n\nExclusion Criteria:\n\n* Age \\<18 y.o.;\n* Preterm gestational age;\n* Multiple pregnancies;\n* Indications for elective cesarean section;\n* Incomplete obstetrical data;\n* Refusal to provide informed consent.\n* Desire to an elective C-Section\n* Controindications for ECV or vaginal delivery (placental abruption, placenta previa, uterine malformations)\n* Reduction of amniotic fluid (AFI \\<4 cm)\n* Uterine contractions\n* Vaginal bleeding\n* Premature rupture of membranes\n* Nonreassuring fetal heart rate patterns before the procedure.'}, 'identificationModule': {'nctId': 'NCT06593795', 'acronym': 'REVERSO', 'briefTitle': 'Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '6366'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group ECV', 'description': 'Pregnant women with a fetus in breech presentation at term of pregnancy undergoing an external cephalic version (ECV) maneuver. This procedure is aimed to induce fetal cephalic position allowing vaginal delivery instead of cesarean section', 'interventionNames': ['Procedure: ultrasound']}], 'interventions': [{'name': 'ultrasound', 'type': 'PROCEDURE', 'description': 'before ECV procedure, an ultrasound will be performed to evaluate\n\n* fetal biometry (BPD, HC, AC, FL, EFW);\n* Occiput position (right, left);\n* Back position (anterior, posterior, right, left);\n* Breech variant (footling, frank, complete);\n* Fetal leg posture (extended, flexed)\n* Placental localization;\n* Amniotic Fluid Index (AFI);\n* Fore-bag of amniotic fluid;\n* Eventual presence of nuchal cords;\n* Fetal head ballottement (yes, no);\n* Occiput-spine angle These parameters will be compared to find predictive factors for successful ECV', 'armGroupLabels': ['Group ECV']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Silvio Tartaglia, MD', 'role': 'CONTACT', 'email': 'silvio.tartaglia@guest.policlinicogemelli.it', 'phone': '(555) 555-1234'}, {'name': 'Sascia Moresi, MD', 'role': 'CONTACT', 'email': 'sascia.moresi@policlinicogemelli.it'}], 'overallOfficials': [{'name': 'silvio tartaglia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'this is an internal database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Carducci Brigida', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}